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Dr Ripal ☆ India, 2016-01-01 06:43 (3830 d 07:54 ago) Posting: # 15789 Views: 6,448 |
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For bio equivalence of ODT tablets, should it be given with water or should it be placed on the tongue without water? Edit: Please follow the Forum’s Policy. [Helmut] |
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drgunasakaran1 ★★  2016-01-02 19:52 (3828 d 18:45 ago) @ Dr Ripal Posting: # 15790 Views: 5,411 |
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Dear Dr Ripal, ❝ For bio equivalence of ODT tablets, should it be given with water or should it be placed on the tongue without water? Kindly let us know the country of submission and molecule name.? If it is Alprazolam ODT and intended country of submission is US FDA, the whole tablet should be placed on the tongue and allowed to disintegrate for 30 seconds. After 30 seconds, all subjects should consume 240 mL of water. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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Dr Ripal ☆ India, 2016-01-04 10:39 (3827 d 03:58 ago) @ drgunasakaran1 Posting: # 15793 Views: 5,185 |
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Dear Dr Gunasakaran, In Alprazolam ODT, it is clear in OGD to put tablet on tongue for 30 sec and administer water later on. In our case no clarity has been provided in the OGD. |
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Helmut ★★★   Vienna, Austria, 2016-01-04 17:35 (3826 d 21:01 ago) @ Dr Ripal Posting: # 15794 Views: 5,167 |
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![[image]](img/uploaded/image77.jpg) Hi Ripal,we neither have a crystal ball nor are we able to read your mind. If you don’t want (or can’t) be more specific, your chances to get a reasonable answer are close to nil. Let me quote from the Forum’s Policy: Some problems are related to a national regulation; in such a case please include the targeted regulatory authority. The EMA’s BE GL contains a section about ODTs. Since you mentioned the OGD would you be so kind and tell us the drug?— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr Ripal ☆ India, 2016-01-06 09:03 (3825 d 05:34 ago) @ Helmut Posting: # 15797 Views: 4,997 |
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We are aiming for clozapine orodispersible tablet. Kindly suggest. |
Ing. Helmut Schütz